This invention relates to the field of medicine, pharmaceuticals, herbal remedies, and specifically to the treatment of chronic idiopathic thrombocytopenic purpura, especially in cases where the patient is refractive to other treatments.
Idiopathic thrombocytopenic purpura (ITP), also known as primary immune thrombocytopenic purpura and autoimmune thrombocytopenic purpura, is defined as isolated thrombocytopenia with normal bone marrow and the absence of other causes for thrombocytopenia. xe2x80x9cIdiopathicxe2x80x9d indicates that the cause is unknown, xe2x80x9cThrombocytopenicxe2x80x9d indicates the blood doesn""t have enough platelets, and xe2x80x9cPurpuraxe2x80x9d indicates a person has excessive bruising. For the two types of ITP, the first type affects children, and the second type affects adults. In children, the usual age of onset for ITP is about two to four years of age. Most adults with ITP are young women, but ITP can occur in anyone.
ITP affects women more frequently than men and is more common in children than adults. There is no sex difference in children. Risk factors are unknown. The incidence is 1 out of 10,000 people.
In the US: The incidence of ITP in adults is approximately 66 cases per 1,000,000 per year. An average estimate of the incidence in children is 50 cases per 1,000,000 per year. New cases of chronic refractory ITP are approximately 10 cases per 1,000,000 per year. Internationally: According to studies in Denmark and England, childhood ITP occurs in approximately 10-40 cases per 1,000,000 per year. A study in Kuwait reported a higher incidence of 125 cases per 1,000,000 per year.
This problem is significant because chronic ITP is one of the major blood disorders in both adults and children. They are a source of significant hospitalization and treatment cost at specialized hematological departments in the US and around the world. Approximately 100,000 people in the US have ITP. The percentage rate of ITP cases is increasing. Each year there are approximately 20,000 new cases in the US. More importantly the cost for ITP care and special therapy is extremely high.
ITP is different in children than in adults. Most children with ITP have a very low platelet count that causes sudden bleeding. The usual symptoms are bruises and the tiny red dots on the skin. Nosebleeds and bleeding gums are also common. Although children often recover with no treatment, many doctors recommend careful observation and mitigation of the bleeding symptoms. Children do not always require hospitalization, and often a short treatment with prednisone pills or intravenous infusions (given in a vein) of gamma globulin to increase the platelet count more quickly. Both treatments, however, have substantial side effects and it is therefore desirable to identify a safe and effective remedy for ITP in children which does not have the side effects of the prednisone pills or gamma globulin.
Typically, in most adults, ITP lasts much longer than it does in children. When diagnosed, many adults present increased bleeding and tend to bruise easily for several weeks, or even months. In women, increased menstrual blood flow is a good indicator of ITP.
In cases of adult mild thrombocytopenia, there are often no bleeding symptoms and the diagnosis of ITP occurs when their blood is checked for another reason and a low blood platelet count is found.
Traditional treatment of ITP in adults is aimed at increasing the blood platelet count by suppressing the immune system which then permits accumulation of platelets without changing the nature of the platelets. This does not the cure the patient of the disease. Patients may take prednisone for several weeks, even a month or longer. However, when the medicine is stopped, platelet counts may return to below normal levels.
With patients refractive to prednisone, a spleenectomy may be indicated. In chronic ITP patients, it is the spleen that makes most of the antibodies that destroy the blood platelets and destroys old or damaged blood cells. Removal of the spleen is a dramatic and permanent alteration of the patient""s body, and includes all the associated potential complications associated with major surgical procedures such as reactions to anesthesia and infection.
In people with ITP, blood cells are normal except for the blood platelets. Platelets are the tiny cells that seal minor cuts and wounds and form blood clots. A person with too few platelets bruises easily and bleeds for a long time after being injured. Tiny red dots on the skin, called petechiae might also appear. When the platelet count is very low, the person with ITP might have nosebleeds that are hard to stop, or might have bleeding in the intestines.
ITP primarily is a disease of increased peripheral platelet destruction, with most patients having antibodies to specific platelet membrane glycoproteins. Relative marrow failure may contribute to this condition, since studies show that most patients have either normal or diminished platelet production. Traditional medical theory purports that platelets and platelet counts would be normal but for the presence of autoimmune antibodies (autoantibodies) made by the patient""s body. Accordingly, traditional medicine attempts to treat a chronic ITP patient by suppressing the immune system, and consequently causing an increase in platelet levels.
Since ITP results from a shortage of platelets, a characteristic bleeding under the skin is often associated with the disease. The disease is believed to be caused when the spleen and lymph tissue produce antibodies against platelets. The antibodies destroy the platelets in the spleen. Symptoms include skin hemorrhage, nosebleed or oral bleeding, easy bruising, abnormal menstrual bleeding, or sudden and severe loss of blood from the gastrointestinal tract may occur, and petechial rash (pinpoint red spots).
Usually, no other abnormal findings are present. In children, the disease is sometimes preceded by a viral infection and runs its course without treatment. In adults, it is usually chronic disease and rarely follows a viral infection.
Acute ITP often follows an acute infection and has a spontaneous resolution within two months. Chronic ITP persists longer than six months without a specific cause.
Hemorrhage represents the most serious complication; intracranial hemorrhage is the most significant. Mortality from hemorrhage is approximately 1% in children and 5% in adults. Older age and previous history of hemorrhage increase the risk of severe bleeding in adult ITP. Spontaneous remission occurs in children in greater than 80% of cases, but it is uncommon in adults.
Diagnosis of chronic ITP often includes examining the patient for an enlarged spleen. Additional tests include CBC with platelet count, bone marrow aspiration or biopsy, PTT (coagulation studies), PT (coagulation studies), platelet associated antibodies, platelet aggregation test Typical treatment of ITP involves initial treatment with prednisone. A splenectomy (removal of the spleen) is indicated if the person does not respond to prednisone. The spleen is the major site of platelet destruction, so a splenectomy will resolve the thrombocytopenia in most people.
Other treatments (when the disease does not respond to initial treatment) are oral danazol, high dose gamma globulin injections, drugs that suppress the immune system, and passage of the blood over a Protein A (Prosorba) column (which filters antibodies out of the blood stream). People with ITP should avoid taking aspirin or ibuprofen, because bleeding may occur.
With acute ITP, the chance of remission is good with prednisone or splenectomy, however, ITP may often become a chronic ailment in adults and reappear even after remission.
The treatment for chronic ITP is indicated generally in patients who are unable to maintain platelet counts consistently over 30,000/xcexcl. Initial specific treatment is corticosteroids and Splenectomy (surgical removal of the spleen) if the first therapy failed. The treatment of patients who fail to respond to corticosteroids and splenectomy is often difficult since these patients tend to be resistant to many forms of treatment. More significantly all types of therapy are either of questionable value, of limited value or require further study. Also, the treatment of all levels is associated with progressively serious early or late side effects. The cost of each therapy is often very high and the administering methods are also complicated. The following is a description of three levels of treatment:
In traditional medicine, first line treatments include using; corticosteroids, splenectomia, vinca alkaloids (vincristine or vinblastine), Danazol (Danocrine), Colchicine, and Dasone. Second line treatments include using; Staph Protein A Column (Prosorba Colum), Cyclophosphamide (cytoxan), and Azathioprine (Immuran). Third line treatments include using; combination chemotherapy, and high-dosage cyclophosphamide. Treatment of questionable or limited benefit include using; Anti-D Antibody, High dosage of Ascorbic Acid (vitamin C), Cyclosporine, Intravenous Immunoglobuline G -IVIG, and Interferon.
All of the above treatments either do not, or rarely cure a patient of chronic ITP. Moreover, each of the compounds and treatments described above have serious side effects, are costly, and generally do not cure the patient. Accordingly, a treatment for chronic idiopathic thrombocytopenic purpura (ITP) or chronic autoimmune thrombocytopenia which is simple to use, has no or little side effects, is needed. Such treatment would include therapeutic compounds which cause quick resolution of the symptoms of chronic ITP, which improves platelet counts and normalizes such for the majority of the treated chronic ITP patients, results in remission and recovery of a high percentage of such patients, which is effective for patients who did not respond to other therapy, which improves the patient""s quality of life and social adaptation, which is effective in patients with refractory ITP, and which causes minimal, if any, adverse side effects.
The invention described herein meets these and other important needs.
In comparison to traditional therapy (whose goal is to destroy or suppress immune system) our unique therapeutic composition not only modulates immunopathological reaction, but also promotes the elimination of the underlying causes of chronic ITP as listed above.
The invention provides, in one aspect, for a composition formed from a decoction or powder of the following ingredients: Radix Astragali and Radix or fresh root of Rehmanniae, in addition to one or more herbs selected from the group consisting of Rhizoma Cyperi, Rhizoma Acori gramenei, Rhizoma Alismatis or Rhizoma Alisma, and Rhizoma Smilacis glabrae. The composition is an effective and safe medicine to treat all forms of chronic ITP in adults and children.
In another aspect, the invention provides for methods and compositions for treating a patient suffering from chronic idiopathic thrombocytopenic purpura, or threatened with chronization of the same, and methods for making the same. In one aspect, the invention provides for an aqueous decoction of a combination of the herbs Radix Astragalus and fresh root of Radix Rehmania glutinosa, and further includes one or more herbs selected from the group consisting of Rhizoma Acori gramenei, Rhizoma Cyperi, Rhizoma Alismatis, and Rhizoma Smilacis glabrae.
In another aspect, the invention provides for a kit for making an aqueous decoction of a composition for treating a patient suffering from chronic idiopathic thrombocytopenic purpura, or threatened with chronization of the same. In some of the preferred embodiments, the kit contains a combination of the herbs Radix Astragalus and Rehmania glutinosa, and further including one or more herbs selected from the group consisting of Rhizoma Acori gramenei, Rhizoma Cyperi, Rhizoma Alismatis, and Rhizoma Smilacis glabrae, in a form adapted for aqueous decocting, and, optionally, instructions for making said aqueous decoction from about equal weight portions of said herbs.
In another aspect, the invention provides for a method for treating a patient suffering from chronic idiopathic thrombocytopenic purpura, or threatened with chronization of the same. In preferred embodiments, the method includes the steps of;
(a) diagnosing said patient as having chronic idiopathic thrombocytopenic purpura by at least measuring blood platelet counts and determining such counts to be below normal,
(b) providing to said patient a decoction of a combination of the herbs Radix Astragalus and fresh root or Radix Rehmania glutinosa, and further including one or more herbs selected from the group consisting of Rhizoma Acori gramenei, Rhizoma Cyperi, Rhizoma Alismatis, and Rhizoma Smilacis glabrae.,
(c) administering said decoction to said patient for a selected period of time,
(d) monitoring said patient blood levels for platelet count, and
(e) discontinuing said administering step upon achieving normal blood platelet counts.
In another aspect, the invention provides for a composition for treating a patient suffering from chronic idiopathic thrombocytopenic purpura, or threatened with chronization of the same. In preferred embodiments, the composition is produced from a method comprising the steps of:
making a combined weight/weight (w/w) ratio of the following weight amounts of herbs including;
(a) providing between about 10 to 50% w/w Rhemania glutinosa herb,
(b) providing between about 5-45% w/w Radix Astragalus herb,
(c) providing between about 0-50% w/w Rhizoma Acori gramenei herb,
(d) providing between about 0-50% Rhizoma Cyperi herb,
(e) providing between about 0-50% w/w Rhizoma Alismatis herb, and
(f) providing between about 0-50% w/w Rhizoma Smilacis glabrae herb,
xe2x80x83such that the combined w/w ratio equals 100%, and
decocting or combining dry said weight amounts of said herbs either individually or in combination or both to form said composition.
In another aspect, the invention provides for a composition for treating a patient suffering from chronic idiopathic thrombocytopenic purpura, or threatened with chronization of the same. In preferred embodiments, the composition includes;
an aqueous decoction or dry formula of a combined weight/weight (w/w) ratio of the following weight amounts of herbs including;
(a) between about 10 to 50% w/w Rhemania glutinosa herb,
(b) between about 5-45% w/w Radix Astragalus herb,
(c) between about 0-50% w/w Rhizoma Acori gramenei herb,
(d) between about 0-50% w/w Rhizoma Alismatis herb,
(e) providing between about 0-50% Rhizoma Cyperi herb, and
(f) between about 0-50% w/w Rhizoma Smilacis glabrae herb,
xe2x80x83such that said combined w/w ratio equals 100%.
In another aspect, the invention provides for a method for treating a patient suffering from chronic idiopathic thrombocytopenic purpura, or threatened with chronization of the same. In preferred embodiments, the method includes the steps of;
(a) diagnosing said patient with having idiopathic thrombocytopenic purpura,
(b) providing (an) aqueous decoction(s) or dry formula of a combined weight/weight (w/w) ratio of the following weight amounts of herbs including;
(i) between about 10 to 50% w/w Rhemania glutinosa herb,
(ii) between about 0-45% w/w Radix Astragalus herb,
(iii) between about 0-50% w/w Rhizoma Acori gramenei herb,
(iv) between about 0-50% w/w Rhizoma Alismatis herb,
(v) between about 0-50% Rhizoma Cyperi herb, and
(vi) between about 0-50% w/w Rhizoma Smilacis glabrae herb,
xe2x80x83such that said combined w/w ratio equals 100%,
(c) administering therapeutic doses of said decoction(s) or dry formula to said patient at selected administration intervals,
(d) monitoring said patient""s blood platelet levels at selected monitoring intervals during said administering step,
(e) ending said administering when said patient""s blood platelet levels become normal.
In another aspect, the invention provides for a method for treating a patient suffering from chronic idiopathic thrombocytopenic purpura, the method comprising the steps of;
(i) stimulating the patient""s immune system by administering to the patient an immunological stimulation or activation agent(s), and stimulating the patient""s stem cell system with a platelet stimulating agent to produce increased amounts of platelets,
(ii) maintaining the patient on the immunological stimulating agent and platelet stimulating agent for a selected period of time having and end period, and
(iii) discontinuing the maintaining until the end period of the selected period of time.
The method above may further include having the immunological stimulating agent and the platelet stimulating agent be supplied in the form of one of the compositions listed above.
The invention provides in a preferred embodiment of one aspect, composition comprising a first component of about 5 to 75% w/w, preferably about 10 to 60% w/w, more preferably about 10-45% w/w, still more preferably about 10 to 30% w/w, yet still more preferably about 10-20% w/w, and particularly preferred at about 20% w/w of Rhemania glutinosa (preferably fresh root). A second component of about 0 to 75% w/w, preferably about 0 to 45% w/w, more preferably about 5 to 30% w/w, still more preferably about 5 to 20%, yet still more preferably about 10 to 20%, and particularly preferred at about 20% w/w of Radix Astragalus. A third component of about 0 to 65% w/w, preferably 0-50% w/w, more preferably about 0 to 30% w/w, still more preferably about 0 to 25%, yet still more preferably about 10 to 25% w/w, and particularly preferred at about 20% w/w of Rhizoma Acori Grameni. A fourth component of about 0 to 65% w/w, preferably 0-50% w/w, more preferably about 0 to 30% w/w, still more preferably about 0 to 25%, yet still more preferably about 10 to 25% w/w, and particularly preferred at about 20% w/w of Rhizoma Alismatis. A fifth component of about 0 to 65% w/w, preferably 0-50% w/w, more preferably about 0 to 30% w/w, still more preferably about 0 to 25%, yet still more preferably about 10 to 25% w/w, and particularly preferred at about 20% w/w of Rhizoma Cyperi. A sixth component of about 0 to 65% w/w, preferably 0-50% w/w, more preferably about 0 to 30% w/w, still more preferably about 0 to 25%, yet still more preferably about 10 to 25% w/w, and particularly preferred at about 20% w/w of Rhizoma Smilacis Glabrae. Each component above is then combined such that the combined w/w ratio of each component equals 100%. Each component of the mixture may be combined and formed into powders for making suspensions, processed into pill form, or decocted or extracted to form, eventually, a concoction of decoctions or extracts.